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McKesson Warned By US FDA Over Illegitimate Product Distribution

McKesson Warned By US FDA Over Illegitimate Product Distribution
San Francisco-based McKesson has been warned against distribution of illegitimate drugs to pharmacies by the US Food and Drug Administration (FDA) under the Drug Supply Chain Security Act (DSCSA) in a strongly worded letter to the company. 
The FDA had notified McKesson in September and October of 2016 that the company had distributed illegitimate products to three separate Rite Aid pharmacies in Michigan.
“The seal of the bottle was broken, and the bottle contained no oxycodone hydrochloride. The bottle contained only 15 tablets, which were later determined to be naproxen,” FDA said in one of the instances.
The finding in the investigation that the oxycodone hydrochloride was likely replaced at a McKesson distribution center was “particularly troubling” for the FDA, the agency found.
“Also troubling is that during the FDA inspection of your firm’s San Francisco headquarters, a McKesson representative stated that incidents involving stolen or diverted controlled substances are not treated as Drug Supply Chain Security Act (DSCSA) verification events within the firm. In fact, DSCSA explicitly defines illegitimate product to include ‘a product for which credible evidence shows that the product is counterfeit, diverted, or stolen,” the report from the FDA noted
A similar scenario was also brought to the attention of McKesson by a pharmacy at an Albertsons grocery store in 2016, where in the pharmacy noted that there was no lot number or expiration date on the two drugs that were received.
“Even after both Albertsons and FDA had contacted you regarding this divalproex and losartan, you did not demonstrate that your firm quarantined all such product or conducted an investigation of the suspect product to determine whether the product was illegitimate,” the warning letter says. “Your firm did subsequently provide what appears to be an inventory listing query, with handwritten notes, that seems to document your inventory check of these products at your Oregon facility.  However, the handwritten notes were undated, unsigned, and were not made available to FDA investigators at the Wilsonville, Oregon, facility, which previously denied receiving the notification to quarantine these products.”
Further, a pharmacy was distributed two sealed bottles of a product labelled as Triumeq which actually contained gemfibrozil. GlaxoSmithKline said in a third example.
“The security of the supply chain, and continued implementation and enforcement of DSCSA, is an important tool in our efforts to ensure that the American public can have confidence in the products they receive, and that illegitimate opioid products do not find their way into the hands of patients,” FDA Commissioner Scott Gottlieb said.
On the other hand, McKesson said in a press statement that the situation had been considered very seriously by it and the company was in communication with the FDA during the last many months to answer the queries of the FDA. Further it said that the company was also in the process of offering more procedural detail and documentation which included enhancements that the company had made recently as a response ot the initial feedback from the FDA. 

Christopher J. Mitchell

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